FDA Medical Device Recalls (openFDA)
Northwest Medical Physics Equipment Inc: ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
- Recall number
- Z-1146-2007
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Product
- ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
- Status
- Terminated
- Initiated
- 2006-04-07
- Posted
- 2007-08-08
- Terminated
- 2011-04-19
- Reason
- This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
- Root cause
- Software design
- Action
- Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.
- Quantity
- 141 copies
- Distribution
- Customers in USA, Korea, Spain and UK.
- Lot, serial or model codes
- ISOLOC 6.5 version, Part Number NT-NW-425-520
- 510(k) numbers
- ["K904908"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000126033
- Firm city
- Everett
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28